Covid19Phase 4NCT04710381
IMUNOR® Preparation in the Prevention of COVID-19
A Phase 4 study testing IMUNOR in people with Covid19, run by University Hospital Ostrava at 1 site in Czechia.
Trial summary
The aim of the study is to achieve prevention of COVID-19 disease in healthcare professionals with the administration of the IMUNOR® preparation, and decreasing the symptoms should the disease appear. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- IMUNOR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Feb 2021to 2 Jun 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Study subjects 18-60 years old
- Ability to cooperate upon the study and to give informed consent
Who cannot join
- Use of any other immunomodulation treatment one month prior to enrolment and in the course of the study
- Acute disease of the cardiovascular, urogenital, respiratory or nervous system
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
About this study
Official title: Pilot, Monocentric, Phase-IV Clinical Trial Assessing the Clinical Effect of Peroral Immunomodulation Treatment Using the IMUNOR® Preparation in the Prevention of COVID-19 Disease
The aim of the study is to achieve prevention of COVID-19 disease in healthcare professionals with the administration of the IMUNOR® preparation, and decreasing the symptoms should the disease appear.
Read the detailed description
This prospective study is designed to collect data for evaluation of the preventive and therapeutic effect of the IMUNOR® preparation, which is commonly used to treat patients with laboratory or clinical manifestations of immunity disorders. Administration of immunomodulation treatment will be based upon a willing informed consent with the administration of the drug and based upon random selection. The study subjects will receive IMUNOR® preventively; the anticipated preventive effect when using one packing (4 vials) is 6 weeks, and 12 weeks when using two packings. Should any signs of acute illness appear (increased body temperature, cough, loss of smell and taste, etc.), a treatment dose of IMUNOR®, i.e. 1 vial/day (total of 4 vials) will be administered immediately. Monitoring of individual patients will take 6 weeks (1 packing) or 12 weeks (2 packings) from the beginning of IMUNOR® administration. The clinical condition of study subjects will be monitored on a daily basis. At the same time, the possible onset of symptoms will be recorded.
The obtained data will be compared with a control group consisting of patients followed by the Department of Preventive Medicine, University Hospital Ostrava.
- Conditions
- Covid19
- Being tested
- IMUNOR
- Keywords
- Covid19, prevention, pork dialyzed leukocyte extract, immunomodulation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMUNORDrug
The intervention consists of the administration of IMUNOR as prevention against COVID-19 disease
| Study group | Role | What they receive |
|---|---|---|
| IMUNOR | Experimental | Study subjects in this arm will receive IMUNOR preparation as prevention against COVID-19 disease. Receives: Drug: IMUNOR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of COVID-19 disease
The incidence of COVID-19 disease among the studied population will be assessed.
Measured: 6 or 12 weeks
Prevention of hospitalisations due to COVID-19
The number of study subjects requiring hospitalisation due to COVID-19 will be observed
Measured: 6 or 12 weeks
Secondary outcomes (1)
Incidence of sick-leave episodes
The number of study subjects requiring a sick-leave due to COVID-19 will be observed
Measured: 6 or 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start1 Feb 2021
- Primary completion2 Jun 2021
- Study completion2 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study treatment (IMUNOR) will be administered to one group of study subjects only.
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaromír Bystroň, Ass.Prof.,MD,CSc., Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710381
- Sponsor's protocol ID
- FNO-IMUNOR-2020
- Status last verified
- Jul 2021
- First submitted
- 13 Jan 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot, Monocentric, Phase-IV Clinical Trial Assessing the Clinical Effect of Peroral Immunomodulation Treatment Using the IMUNOR® Preparation in the Prevention of COVID-19 Disease
- ClinicalTrials.gov ID
- NCT04710381
- Acronym / sponsor ID
- FNO-IMUNOR-2020
- Conditions
- Covid19
- Keywords
- Covid19, prevention, pork dialyzed leukocyte extract, immunomodulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 2 Jun 2021 (actual)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to achieve prevention of COVID-19 disease in healthcare professionals with the administration of the IMUNOR® preparation, and decreasing the symptoms should the disease appear.
Detailed description
This prospective study is designed to collect data for evaluation of the preventive and therapeutic effect of the IMUNOR® preparation, which is commonly used to treat patients with laboratory or clinical manifestations of immunity disorders. Administration of immunomodulation treatment will be based upon a willing informed consent with the administration of the drug and based upon random selection. The study subjects will receive IMUNOR® preventively; the anticipated preventive effect when using one packing (4 vials) is 6 weeks, and 12 weeks when using two packings. Should any signs of acute illness appear (increased body temperature, cough, loss of smell and taste, etc.), a treatment dose of IMUNOR®, i.e. 1 vial/day (total of 4 vials) will be administered immediately. Monitoring of individual patients will take 6 weeks (1 packing) or 12 weeks (2 packings) from the beginning of IMUNOR® administration. The clinical condition of study subjects will be monitored on a daily basis. At the same time, the possible onset of symptoms will be recorded.
The obtained data will be compared with a control group consisting of patients followed by the Department of Preventive Medicine, University Hospital Ostrava.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study treatment (IMUNOR) will be administered to one group of study subjects only.
| Arm | Type | Receives |
|---|---|---|
| IMUNOR | Experimental | Drug: IMUNORStudy subjects in this arm will receive IMUNOR preparation as prevention against COVID-19 disease. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Study subjects 18-60 years old
- Ability to cooperate upon the study and to give informed consent
Key exclusion criteria (2 listed)
- Use of any other immunomodulation treatment one month prior to enrolment and in the course of the study
- Acute disease of the cardiovascular, urogenital, respiratory or nervous system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMUNORThe intervention consists of the administration of IMUNOR as prevention against COVID-19 disease | Drug | IMUNOR |
Primary outcome
Prevention of COVID-19 disease
Time frame: 6 or 12 weeks
The incidence of COVID-19 disease among the studied population will be assessed.
Prevention of hospitalisations due to COVID-19
Time frame: 6 or 12 weeks
The number of study subjects requiring hospitalisation due to COVID-19 will be observed
1 secondary outcome
Incidence of sick-leave episodes
Time frame: 6 or 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaromír Bystroň, Ass.Prof.,MD,CSc. principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IMUNOR in people with Covid19, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of COVID-19 disease (time frame: 6 or 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.